Technical Specifications - HemoCue Hb 301 Manuel D'utilisation

Point-of-care studies
Point-of-care studies have been performed at three individual district
health centers in primary care with both nursing and physician services.
The studies were performed on capillary samples in duplicates tested on
HemoCue Hb 301 vs HemoCue Hb 201
against the International Council for Standardization in Haematology
method (ICSH) using venous blood (2).
3
Study N Min Max Regression
g/dL g/dL line
1 186 8.3 18.0 Y = 0.897x +
1.357
2 700 1.6 23.0 Y = 1.005x
-0.041

Technical Specifications

Dimensions: 160 x 140 x 70 mm (6.29 x 5.51 x 2.76 inches)
Weight: 500 g (1.10 pounds) (with batteries installed)
4 batteries type AA
Power adapter: CE marked
Only use adapters, as listed under "Adapters".
Pollution degree: 2
Overvoltage category: II
Atmospheric pressure: 700 hPa to 1060 hPa.
Equipment not suitable for use in the presence of flammable
mixtures.
The instrument is tested according to
• IEC/EN 61010-1, 2001
• IEC/EN 60601-1 2:nd edition clause 19, 20 and 57.10
(Leakage current, dielectric strength and insulation distance)
• IEC/EN 60601-1-2
• IEC/EN 61326
and complies with the IVD Medical Device Directive 98/79/EC.
The instrument is made for continuos mode.
Adapters
Country: EU/US/GB
Type: FW7333SM/12
Input: 100 V~-240 V~/50–60 Hz/<200 mA
(1). The Hb 201 was verified
+ +
Country: EU/US/GB
Type: HCA01
Input: 100 V~-240 V~/50–60 Hz/<500 mA
Correlation
Warnings
coefficient (r)
The device is tested according to standard IEC/EN 60601-1-2 and is
found to comply with the standard.
0.930
Despite this compliance it is impossible to predict any possible effects
by other nearby standing instruments, (stationary, portable or mobile
0.999
units) or the possible impact of electromagnetic radiance. This is the
reason we need to inform users of this analyzer that disturbance from
other equipment might affect the performance of the analyzer. Should
you note that this is the fact, please contact your local HemoCue
distributor.
The HemoCue Hb 301 is intended for use in the electromagnetic
environment specified in Technical specifications. The customer or user
of the HemoCue Hb 301 system should assure that it is used in such an
environment. The HemoCue Hb 301 Analyzer uses RF energy only for
its internal function. Therefore, its RF emissions are very low and not
likely to cause any interference in nearby electronic equipment.
The HemoCue Hb 301 system is suitable for use in all establishments,
including domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings used
for domestic purposes.
Accessory equipment connected to the analog and digital interfaces
must be certified according to the respective IEC standards (i.e. IEC
60950-1 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore all configurations must comply with the
system standard, IEC 60601-1-1. Connections of additional equipment
to the signal input or signal output connections is deemed to be
"configuring a medical system", and therefore assumes responsiblity
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